The drug, Vedolizumab, aims to treat symptoms of both Crohn's disease and ulcerative colitis, both of which are extremely painful and debilitating plagues on the abdominal tract.

Results have been quite positive, so we asked David T. Rubin, MD, Professor of Medicine and Co-Director of the Inflammatory Bowel Disease Center at The University of Chicago Medicine to weigh in on this budding wonder drug.

Q: What are the larger implications of this potential IBD treatment?

A: Vedolizumab is a highly anticipated novel therapy for patients with IBD. It is effective for induction and stable maintenance of remission in ulcerative colitis and for stable maintenance in Crohn’s disease. The combination of the two studies represents the largest number of patients in a clinical trial program for IBD.

One of the most striking messages about these two placebo-controlled studies is that this gut-specific therapy had a remarkable safety profile — similar to placebos across almost all parameters. This is a completely new mechanism of action in the ulcerative colitis space and offers the promise of improvement over the existing inhibitors in Crohn’s disease since it does not involve the brain.

Q: How does the effect of Vedolizumab differ in regard to Crohn's disease and ulcerative colitis?

A: Vedolizumab was superior to placebo in response, steroid-free remission and durable remission in patients with moderate to severe Crohn's disease. The study demonstrated some important signals of efficacy, but also reinforced some of the emerging endpoints of interest in IBD. The difference between the Crohn’s results — in which the primary endpoint of remission at 6 weeks was missed — and the ulcerative colitis results — in which all primary and secondary endpoints were achieved — may be due to many reasons.

Crohn’s disease is a substantially more heterogeneous disease than ulcerative colitis. Crohn’s patients entering clinical trials tend to have long disease duration and, unlike ulcerative colitis, there is often disease progression and fibrosis over time, which may result in lower responses to anti-inflammatory therapies. Crohn’s disease is a full thickness inflammation in many patients and therefore this treatment strategy may not be appropriate for some patients or for patients who have already developed penetrating, internal complications like fistulas.

However, there are important messages in the Crohn’s study results:

First, there is the ability to predict stable response and disease control based on an early time point — six weeks. This prognostic information is extremely useful since providing patients and doctors with a better understanding of how long they should wait before knowing if the therapy is working is quite important, and also because knowledge of subsequent disease stability can reinforce adherence to therapy and ongoing treatment.

Second, we are greatly interested in steroid-sparing properties of our IBD therapies, since we know the adverse effects of steroids.

Third, among 80 percent of the time points assessed, the patient remained in remission. This is extremely important and helps us to understand the distinction between an aggregate cross-sectional endpoint and a summary of all time points throughout the study. Positive results for durable remission reflect patients who not only have responded to therapy, but have done so with little or no breakthrough in subsequent follow-up, and has direct implications for quality of life and other downstream outcomes.

Q: How will Vedolizumab be implemented for potential IBD treatment?

A: We would like to see the option of treating both Crohn’s disease and ulcerative colitis patients who are anti-TNF (tumor necrosis factor) therapy naïve and those who have failed anti-TNF therapies. This would help us use this gut-specific treatment prior to systemic therapies in appropriate patients.

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